Cosmetics & Personal Care | Monthly bulletin | June 2024

Breaking ground in solar testing: Innovations and standards update

The "Alt-SPF" program, managed by a consortium of cosmetics companies and CROs, including Eurofins Cosmetics & Personal Care, is currently analysing five alternative techniques.

During the 29th ISO/TC 217/WG 7 meeting in Berlin, two out of five alternative ISO methods—ISO/DIS 23675 (In Vitro SPF) and ISO/DIS 23698 (HDRS)—were proposed to advance to the Final Draft for International Standard (FDIS).

The 23675 in vitro SPF test method is based on UVR transmittance spectroscopy, which involves spectrophotometric measurement of UVR transmission through suitable UVR-transparent substrates (two types of artificial tiles) to predict in vivo SPF values. This approach can be applied to sunscreen products in emulsion or alcoholic one-phase formulations, except for loose or compressed powder or stick forms.

The hybrid diffuse reflectance spectroscopy (HDRS) method, also known as the 23698 method, is a non-invasive optical evaluation of the protection provided by topically applied sunscreen products, measured in situ on human skin. It does not require physiological responses from the test subject and does not cause any erythema. This technique explains how to assess sunscreen products' critical wavelength (CW), UVA protection factor (UVA-PF), and sun protection factor (SPF) without needing biological reactions. It has been validated for both single-phase and emulsion products.

Initially, these methods will only be valid for static SPF. Stress tests (e.g., water resistance, sweat resistance) are not covered by these standards initially but are expected to be included later.

Currently, for the determination of static SPF and especially for tests with water resistance, the official methods remain:

Europe: SPF ISO 24444: 2019 / Amd.1: 2022 combined with ISO16217:2020 / ISO18861:2020
USA: FDA 2011
Australia and New Zealand: AS/NZS 2604:2021

However, static SPF screening tests can be conducted using the "double plate" method on sunscreen products in emulsion or alcoholic one-phase formulations.

Changes are anticipated in FDA methods, underscoring the importance of staying informed about current and future regulatory developments in solar testing, including in South Korea, Australia, and New Zealand.

Eurofins Cosmetics & Personal Care is committed to remaining informed about current and future regulatory developments in solar testing, supported by a team of experts actively engaged in standardisation across various committees such as the ALT-SPF Consortium and ISO members.

Regulatory spotlight: Addressing PFAS concerns in cosmetics

PFAS (Per- and polyfluoroalkyl substances) are at the center of current regulatory concerns due to their environmental persistence and harmful health effects. In 2024, several important initiatives were taken to restrict their use, particularly in cosmetics.

In Europe, a major proposal to restrict PFAS is currently being evaluated by ECHA (European Chemicals Agency) under the REACH regulation. This proposal, submitted by several countries (Denmark, Germany, the Netherlands, Norway and Sweden), aims to restrict the manufacture and use of PFAS in the European Union. The measure could come into force after 2026 and is one of the most far-reaching restrictions in EU history.

In France, the PFAS 2023-2027 action plan has been put in place to reinforce protection against the risks associated with these substances. This plan includes measures such as setting discharge standards, improving knowledge of exposure in aquatic environments, and significantly reducing industrial emissions of PFAS. In addition, a bill has been passed to ban PFAS in cosmetics, clothing and waxes from 2026.

These regulations aim to reduce the risks associated with PFAS, which are present in many consumer products, including cosmetics where they are used for their waterproofing and heat-resistant properties.

As a leader in analytical testing, the Eurofins Cosmetics & Personal Care network has developed a test protocol to determine PFAS in your cosmetics and packaging products. This ensures that your products are safe for end users.

Navigate Canada's new cosmetic regulations with confidence!

Canada has recently updated its regulations on cosmetics, including fragrances, to better protect the health of consumers and the environment.

Health Canada is enhancing consumer protection by mandating the disclosure of specific fragrances on cosmetic labels, aligning with global trends, especially in Europe. The amendment to Canada's cosmetic regulations introduces new requirements for ingredient transparency.

Key points relating to the Amendment:

Disclosure of Allergens: Health Canada now mandates the disclosure of all ingredients that could cause allergic reactions, specifically certain fragrance allergens on cosmetic labels, moving away from the blanket term "parfum." This aligns with European standards and empowers consumers to make informed choices. "Fragrance free” or "Unscented" will not be reviewed by Health Canada.
Definition Updates: The amendment clarifies the roles of manufacturers and importers, including provisions for foreign brand owners appointing local representatives. This ensures accountability and consistency in regulatory compliance.
Digital Labelling for Small Packages: Recognising the challenges in labelling small packages, Health Canada allows for ingredient disclosure online. This balances the need for safety information accessibility while maintaining regulatory compliance.
Enforcement Measures: Health Canada's ability to issue stop sale orders for non-compliant cosmetics underscores the importance of timely notification submissions, enhancing regulatory oversight and consumer safety.

These changes are designed to harmonise Canadian regulations with European standards, and to enhance safety and transparency for consumers.

Eurofins Cosmetics & Personal Care is dedicated to helping you navigate the latest amendments to Canada’s cosmetic regulations. As a trusted partner in the cosmetics and personal care industry, we are committed to supporting your compliance efforts, enhancing transparency, and ensuring consumer safety. Contact us today to learn how we can assist you in adapting to these regulatory changes.